The following data is part of a premarket notification filed by Clincal Instruments Corp. with the FDA for Multilumen Intravenous Infusion Catheter.
Device ID | K821220 |
510k Number | K821220 |
Device Name: | MULTILUMEN INTRAVENOUS INFUSION CATHETER |
Classification | Catheter, Multiple Lumen |
Applicant | CLINCAL INSTRUMENTS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GBP |
CFR Regulation Number | 878.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-04-27 |
Decision Date | 1982-07-09 |